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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Silver Spring MD 20993

NDA 204516NDA APPROVAL

Noven Therapeutics, LLC

Attention: Snehal Shah, Pharm.D.

Director, Regulatory Affairs

Empire State Building350 Fifth Avenue, 37

thFloor

New York, NY 10118

Dear Dr. Shah:

Please refer to your New Drug Application (NDA) dated and received August 28, 2012,

submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA)

for BRISDELLE (paroxetine) capsules, 7.5 mg, for oral use.

We also refer to our approval letter dated June 28, 2013, which contained the following error: the

enclosed agreed-upon labeling text identified the Initial U.S. Approval date in the Highlights of

Prescribing Information section as 2003; it should be 1992.

This replacement approval letter incorporates the correction of the error. The effective approval

date will remain June 28, 2013, the date of the original approval letter.

We acknowledge receipt of your amendments dated September 20, October 3, November 19,

December 7, December 12, December 17, and December 26, 2012; January 7, January 16, March26, April 25, April 26, May 1, May 8, June 26, June 27, and June 28, 2013.

This new drug application provides for the use of BRISDELLE (paroxetine) capsules for the

treatment of moderate to severe vasomotor symptoms associated with menopause.

We have completed our review of this application, as amended. It is approved, effective June 28,

2013, for use as recommended in the enclosed agreed-upon labeling text.

CONTENT OF LABELING

As soon as possible, but no later than 14 days from the date of this letter, submit the content oflabeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA

automated drug registration and listing system (eLIST), as described at

http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Contentof labeling must be identical to the enclosed labeling (text for the package insert, Medication

Reference ID: 3338122
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htmhttp://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm

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NDA 204516Page 2

Guide). Information on submitting SPL files using eLIST may be found in the guidance forindustry SPL Standard for Content of Labeling Technical Qs and As, available at

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U

CM072392.pdf. The SPL will be accessible via publicly available labeling repositories.

CARTON AND IMMEDIATE-CONTAINER LABELS

Submit final printed carton and immediate-container labels that are identical to the carton andimmediate-container labels submitted on June 27, 2013, as soon as they are available, but no

more than 30 days after they are printed. Please submit these labels electronically according to

the guidance for industry Providing Regulatory Submissions in Electronic Format HumanPharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

(June 2008). Alternatively, you may submit 12 paper copies, with 6 of the copies individually

mounted on heavy-weight paper or similar material. For administrative purposes, designate thissubmission Final Printed Carton and Container Labels for approved NDA 204516. Approval

of this submission by FDA is not required before the labeling is used.

Marketing the products with FPL that is not identical to the approved labeling text may renderthe product misbranded and an unapproved new drug.

REQUIRED PEDIATRIC ASSESSMENTS

Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new

active ingredients, new indications, new dosage forms, new dosing regimens, or new routes ofadministration are required to contain an assessment of the safety and effectiveness of the

product for the claimed indication(s) in pediatric patients unless this requirement is waived,

deferred, or inapplicable.

We are waiving the pediatric study requirement for this application because necessary studies are

impossible or highly impracticable (the disease/condition does not exist in children).

PROMOTIONAL MATERIALS

You may request advisory comments on proposed introductory advertising and promotionallabeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the

proposed materials in draft or mock-up form with annotated references, and the package insert

to:

Food and Drug AdministrationCenter for Drug Evaluation and ResearchOffice of Prescription Drug Promotion5901-B Ammendale RoadBeltsville, MD 20705-1266

As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the

package insert, at the time of initial dissemination or publication, accompanied by a Form FDA

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/Uhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U

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NDA 204516Page 3

2253. For instruction on completing the Form FDA 2253, see page 2 of the Form. For moreinformation about submission of promotional materials to the Office of Prescription Drug

Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.

REPORTING REQUIREMENTS

We remind you that you must comply with reporting requirements for an approved NDA

(21 CFR 314.80 and 314.81).

If you have any questions, call Kim Shiley, R.N., B.S.N., Regulatory Project Manager, at (301)

796-2117.

Sincerely,

{See appended electronic signature page}

Hylton V. Joffe, M.D., M.M.Sc.DirectorDivision of Bone, Reproductive, and Urologic Products

Office of Drug Evaluation III

Center for Drug Evaluation and Research

Enclosures:

Content of Labeling

Carton and Container Labeling

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htmhttp://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm

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This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.

/s/

HYLTON V JOFFE

06/28/2013


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